Convival Hrono

Leaflet attached to the packaging: information for the user

Convival Chrono, 300 mg, prolonged-release tablets

Sodium valproate
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see point 4.

WARNING

Convival Chrono (sodium valproate) used during pregnancy can harm the unborn child. Women of childbearing age should use effective contraception (birth control) without interruption throughout the entire treatment period with Convival Chrono. The treating doctor will discuss this with the patient, and it is also necessary to follow the recommendations presented in point 2 of this leaflet.
It is necessary to contact the treating doctor immediately if the patient plans to become pregnant or suspects that she is pregnant.
Do not stop taking Convival Chrono unless the doctor advises it, as the patient's condition may worsen.
It is necessary to carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• It is necessary to keep this leaflet so that it can be re-read if necessary.
• In case of any doubts, it is necessary to consult a doctor or pharmacist.
• This medicinal product has been prescribed to a specific person. Do not pass it on to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See point 4.

Table of contents of the leaflet:

• 1. What is Convival Chrono and what is it used for
• 2. Important information before taking Convival Chrono
• 3. How to take Convival Chrono
• 4. Possible adverse reactions
• 5. How to store Convival Chrono
• 6. Contents of the packaging and other information

1. What is Convival Chrono and what is it used for

Convival Chrono has the form of prolonged-release tablets and contains the active substance sodium valproate, which belongs to the group of antiepileptic drugs and acts on the central nervous system.
The medicinal product has anticonvulsant activity in various forms of epilepsy in humans.
Convival Chrono is a medicinal product used to treat epilepsy and mania.
Convival Chrono is used to treat:

• epilepsy, in generalized seizures:
• myoclonic seizures,
• tonic-clonic seizures,
• atonic seizures,
• seizures of unknown origin, in partial seizures:
• simple or complex seizures,
• secondarily generalized seizures,
• Lennox-Gastaut syndrome.
• Mania, which is a state in which the patient feels very excited, happy, stimulated, enthusiastic, or overactive. Mania occurs in a disease called bipolar affective disorder. Convival Chrono may be used in cases where lithium cannot be used.

2. Important information before taking Convival Chrono

When not to take Convival Chrono:

Do not take the medicinal product in the following cases:

• if the patient is hypersensitive to the active substance sodium valproate or to any of the other ingredients of this medicinal product (listed in point 6),
• if the patient has acute or chronic liver disease,
• if the patient has had severe liver disease, especially drug-induced or if the patient's family history indicates severe liver disease,
• if the patient has porphyria (a very rare metabolic disorder),
• concomitant use with mefloquine,
• if the patient has a genetic disorder causing mitochondrial disorders (e.g., patients with Alpers-Huttenlocher syndrome),
• if the patient has metabolic disorders, such as disorders of the urea cycle.
• bipolar affective disorder:
• if the patient is pregnant,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Do not stop taking Convival Chrono or contraception until this has been discussed with the doctor. The treating doctor will provide further guidance.
• epilepsy:
• if the patient is pregnant, unless no other therapy is effective,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Do not stop taking Convival Chrono or contraception until this has been discussed with the doctor. The treating doctor will provide further guidance.

Warnings and precautions

• Before starting treatment and periodically during the first 6 months of treatment, it is recommended to perform laboratory tests of liver function.
• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or recurrence of seizures, especially during the first 6 months of treatment, it is necessary to inform the treating doctor immediately.
• Rarely, Convival Chrono may cause severe liver damage that can be life-threatening.
• In case of severe abdominal pain, it is necessary to inform the treating doctor immediately. Very rarely, Convival Chrono may cause severe pancreatitis, which can be life-threatening.
• Sodium valproate should not be used in women with epilepsy who are planning to become pregnant, unless other treatments are ineffective or not tolerated. It is necessary to consider the benefits of using the medicinal product in relation to the risk before the first prescription or when a woman treated with sodium valproate plans to become pregnant.

with the use of sodium valproate during pregnancy (regardless of the disease for which sodium valproate is used)

• It is necessary to consult the treating doctor immediately if the patient plans to become pregnant or is pregnant.
• Taking sodium valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free.
• Sodium valproate may cause serious birth defects and affect the development of the growing child. The most common birth defects reported include spinal bifida (when the spine is not properly developed); developmental abnormalities of the face and skull; developmental abnormalities of the heart, kidneys, urinary tract, and genital organs, as well as multiple related developmental abnormalities affecting several organs and body parts. Birth defects can cause disability, which can be significant.
• Children exposed to sodium valproate in utero have reported hearing problems or deafness.
• Children exposed to valproate in utero have reported developmental eye abnormalities along with other birth defects. Developmental eye abnormalities can affect vision.
• It is estimated that about 10 out of 100 children born to mothers who took sodium valproate during pregnancy will have birth defects. For comparison, birth defects are found in 2-3 out of 100 children born to women without epilepsy.
• About 30-40% of preschool-age children whose mothers took sodium valproate during pregnancy may exhibit early developmental problems. Children with this condition may start walking and talking later, be less intellectually agile than other children, have language problems, and have memory problems.
• Children exposed to sodium valproate are more likely to be diagnosed with various autistic disorders. Some evidence suggests an increased risk of developing attention deficit hyperactivity disorder (ADHD) in these children.
• Before prescribing this medicinal product, the treating doctor will explain to the patient what may endanger the child if the patient becomes pregnant while taking sodium valproate. If the patient taking this medicinal product decides to have a child, she should not stop taking the medicinal product or contraception without discussing it with the treating doctor.
• Parents or guardians of girls treated with sodium valproate should contact the treating doctor when their child starts menstruating.
• Some contraceptives (oral contraceptives containing estrogen) may decrease the level of sodium valproate in the blood. It is necessary to discuss the method of contraception with the doctor.
• It is necessary to ask the doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with sodium valproate treatment.

Please select one of the following situations that applies to the patient and read the information:

• STARTING TREATMENT WITH CONVIVAL CHRONO
• CONTINUING TREATMENT WITH CONVIVAL CHRONO WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH CONVIVAL CHRONO WHILE TRYING TO CONCEIVE
• UNPLANNED PREGNANCY DURING CONTINUING TREATMENT WITH CONVIVAL CHRONO

STARTING TREATMENT WITH CONVIVAL CHRONO

If Convival Chrono is prescribed for the first time, the treating doctor will explain the risk to the unborn child if the patient becomes pregnant. Women of childbearing age should ensure that they use effective contraception throughout the entire treatment period with Convival Chrono. It is necessary to consult the treating doctor or a family planning clinic if the patient needs advice on contraception.

Important information:

• Before starting treatment with Convival Chrono, it is necessary to rule out pregnancy using a pregnancy test, the results of which will be confirmed by the treating doctor.
• The patient should use effective contraception throughout the entire treatment period with Convival Chrono.
• It is necessary to discuss contraception with the treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• It is necessary to regularly (at least once a year) visit a specialist treating bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking sodium valproate during pregnancy.
• It is necessary to inform the doctor if the patient plans to have a child.
• It is necessary to immediately inform the doctor if the patient is pregnant or suspects that she may be pregnant.

CONTINUING TREATMENT WITH CONVIVAL CHRONO WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with Convival Chrono and does not plan to become pregnant, she must ensure that she uses effective contraception throughout the entire treatment period with Convival Chrono. It is necessary to consult the doctor or a family planning clinic if the patient needs advice on contraception.

Important information:

• The patient should use effective contraception throughout the entire treatment period with Convival Chrono.
• It is necessary to discuss contraception with the treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• It is necessary to regularly (at least once a year) visit a specialist treating bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking sodium valproate during pregnancy.
• It is necessary to inform the doctor if the patient plans to have a child.
• It is necessary to immediately inform the doctor if the patient is pregnant or suspects that she may be pregnant.

CONTINUING TREATMENT WITH CONVIVAL CHRONO WHILE TRYING TO CONCEIVE

TO CONCEIVE

If the patient plans to have a child, she should first make an appointment with the treating doctor. She should not stop taking Convival Chrono or contraception without discussing it with the treating doctor. The treating doctor will provide further guidance.
Children born to mothers who took sodium valproate are at serious risk of birth defects and developmental problems, which can significantly affect the child. The treating doctor will refer the patient to a specialist treating bipolar affective disorder or epilepsy to assess alternative treatment options. The specialist may take actions to ensure the best possible course of pregnancy and minimize the risk to the mother and unborn child.
The specialist may decide to change the dose of Convival Chrono, switch to another medicinal product, or stop treatment with Convival Chrono long before becoming pregnant – to ensure that the disease is stable.
It is necessary to ask the doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with sodium valproate treatment.

Important information:

• Do not stop taking Convival Chrono unless the doctor decides to do so.
• Do not stop using contraception before discussing it with the treating doctor and developing a plan to ensure control of the patient's condition and minimize the risks to the child.
• First, it is necessary to make an appointment with the treating doctor. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking sodium valproate during pregnancy.
• The treating doctor will try to switch to another medicinal product or stop treatment with Convival Chrono long before becoming pregnant.
• It is necessary to immediately inform the doctor if the patient is pregnant or suspects that she may be pregnant.

UNPLANNED PREGNANCY DURING CONTINUING TREATMENT WITH CONVIVAL CHRONO

Do not stop taking Convival Chrono unless the doctor advises it, as the patient's condition may worsen. It is necessary to make an urgent appointment with the treating doctor if the patient is pregnant or suspects that she may be pregnant. The treating doctor will provide further guidance.
Children born to mothers who took sodium valproate are at serious risk of birth defects and developmental problems, which can significantly affect the child. The patient will be referred to a specialist treating epilepsy or bipolar affective disorder to assess alternative treatment options.
In exceptional cases, when Convival Chrono is the only available treatment option during pregnancy, the patient will be closely monitored, both in terms of the underlying disease and fetal development. The patient and her partner will receive counseling and support regarding pregnancy exposed to sodium valproate.
It is necessary to ask the doctor about taking folic acid. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with sodium valproate treatment.

Important information:

• It is necessary to schedule an urgent appointment with the treating doctor if the patient is pregnant or suspects that she may be pregnant.
• Do not stop taking Convival Chrono unless the doctor advises it.
• The patient must be referred to a specialist treating epilepsy or bipolar affective disorder to assess the need for alternative treatment options.
• The patient must receive counseling on the risks associated with taking Convival Chrono during pregnancy, including its teratogenic effects and impact on child development.
• The patient must be referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

Newborns of mothers who took Convival Chrono during pregnancy may experience coagulation disorders, hypoglycemia, hypothyroidism, and withdrawal symptoms such as irritability, restlessness, hyperactivity, tremors, seizures, and feeding problems.

Please read the patient guide provided by the treating doctor. The treating doctor will discuss the annual confirmation form regarding the risks and ask the patient to sign and keep it. The patient will also receive a patient card from the pharmacist

to remind them of the risks associated with taking sodium valproate during pregnancy.

Important information for male patients

Possible risk associated with taking valproate in the 3 months before conception
A study suggests a possible risk of motor disorders and developmental delays (problems with early childhood development) in children whose fathers were treated with valproate in the 3 months before conception. In this study, such disorders occurred in about 5 out of 100 children whose fathers were treated with valproate, compared to about 3 out of 100 children of men treated with lamotrigine or levetiracetam (other medicinal products that may be used to treat the patient's disease). The risk to children whose fathers stopped taking valproate at least 3 months (the time needed to produce new sperm) before conception is unknown.
The study has limitations, and therefore, it is not clear whether the increased risk of developmental disorders suggested by the study is caused by valproate. The study was not large enough to show what specific types of motor disorders and developmental delays are associated with this risk.
As a precaution, the doctor will discuss with the patient:

• the possible risk to children whose fathers were treated with valproate;
• the need to use effective contraception by the patient and their partner during treatment and for 3 months after its completion;
• the need to consult a doctor when planning to conceive and before stopping contraception;
• the possibility of using other treatment methods for the disease, depending on the individual situation.

Do not donate sperm while taking valproate and for 3 months after stopping it. If the patient plans to have a child, they should discuss it with their doctor.
If the patient's partner becomes pregnant while the patient is taking valproate in the 3 months before conception, and the patient has questions related to this, they should contact their doctor. Do not stop taking the medicinal product without consulting a doctor. If the patient stops taking the medicinal product, their symptoms may worsen.
The patient should regularly visit the doctor who prescribed the medicinal product. During such a visit, the doctor will discuss the precautions associated with taking valproate and the possibility of using other treatment methods for the disease, depending on the individual situation of the patient.
It is necessary to read the patient guide provided by the treating doctor. The patient will also receive a patient card from the pharmacist to remind them of the possible risk associated with taking valproate.

Driving and using machines

In some patients, during treatment, drowsiness may occur, especially when using several antiepileptic drugs or when using benzodiazepines concomitantly. Before driving or operating machinery, the patient should make sure how they react to the treatment.

Convival Chrono contains sodium

This medicinal product contains 42 mg of sodium (the main component of table salt) per tablet. This corresponds to 2.1% of the recommended maximum daily intake of sodium in the diet for adults.

3. How to take Convival Chrono

Girls and women of childbearing age

Convival Chrono should always be taken according to the doctor's instructions. In case of doubts, it is necessary to consult a doctor.

Male patients

It is recommended that the use of Convulex be started and supervised by a specialist in the treatment of epilepsy or bipolar affective disorder – see point 2 Important information for male patients.
Treatment with Convival Chrono should be started and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.
The use of a prolonged-release formulation allows Convival Chrono to be taken in a single daily dose or in 2 divided doses per day.
If there are indications, Convival Chrono prolonged-release tablets may be used in children over 17 kg of body weight, provided that the child can swallow the tablet. This formulation is not suitable for children under 6 years of age (risk of choking).
The daily dose of Convival Chrono should be determined based on the patient's age and body weight, and the doctor should always consider the patient's individual sensitivity to sodium valproate.
Changing therapy to prolonged-release formulations
In the case of switching from conventional tablets to prolonged-release tablets, it is recommended (according to current knowledge) to maintain the same daily dose.
Starting treatment with Convival Chrono in epilepsy
When starting treatment with Convival Chrono as the only antiepileptic drug, the dose should be increased every 2-3 days to reach the average recommended dose in one week.
When introducing Convival Chrono in patients already taking other antiepileptic drugs, it is necessary to gradually increase the dose of Convival Chrono over a period of 2 weeks to reach the average recommended dose. Then, the dose of the other antiepileptic drugs should be reduced to a level that ensures optimal control of seizures or discontinued if possible.
In case of need to add other antiepileptic drugs to the therapy, they should be introduced gradually.
The initial daily dose is usually 5 to 15 mg/kg of body weight and should be gradually increased every 2-3 days by 5 mg/kg of body weight to reach the optimal dose (see: Starting treatment with Convival Chrono).
Usually, the daily dose is 20 to 30 mg/kg of body weight, given in one or two divided doses.
If necessary, the daily dose may be even higher than 50 mg/kg of body weight, provided that the patient is under close clinical supervision (see: Take special care when taking Convival Chrono).
Children over 17 kg of body weight
The average dose is 30 mg/kg of body weight per day.
Adults
The average dose is 20 to 30 mg/kg of body weight per day.
Elderly patients
Dosing should be based on the control of seizures.
Patients with renal impairment
The doctor may decide to modify the dose in the patient.
Mania
Adults
The daily dose should be determined and checked individually by the treating doctor.
Initial dose:
The recommended initial daily dose is 750 mg.
Average daily dose:
The average daily dose is usually between 1000 mg and 2000 mg.
Duration of treatment
The medicinal product should be taken for as long as the doctor recommends.
If the patient feels that the effect of Convival Chrono is too strong or too weak, they should consult their doctor.

Taking a higher dose of Convival Chrono than recommended

Symptoms of severe overdose of valproate derivatives include: drowsiness, decreased muscle tone and reflexes, narrowing of the pupils; metabolic acidosis, decreased blood pressure, and acute cardiovascular failure may also occur. Other symptoms may also occur, including seizures in cases of very high levels of the medicinal product in the blood. Cases of increased intracranial pressure associated with cerebral edema have been reported. The presence of sodium in valproate formulations may lead to increased sodium levels in the blood in case of overdose of the medicinal product.
In case of taking a higher dose of Convival Chrono than recommended, it is necessary to immediately consult a doctor or pharmacist.
Hospital treatment in case of poisoning should include: gastric lavage (up to 10-12 hours after taking the medicinal product), constant monitoring of cardiovascular and respiratory function. In severe cases, hemodialysis or even exchange transfusion may be necessary.

Missing a dose of Convival Chrono

In case of missing a dose of Convival Chrono, it is necessary to take it as soon as possible, unless the time for the next dose is approaching.
Do not take two doses of the medicinal product at the same time or at short intervals. In case of doubts, it is necessary to consult a doctor.

4. Possible Undesirable Effects

Like all medicines, Convival Chrono can cause undesirable effects ,although they do not occur in every patient. They are rarely serious; usually, they are transient. However, patients may require appropriate treatment in case of the occurrence of certain undesirable effects.
Undesirable effects are presented according to the following frequency classification:
Very common (may occur more frequently than 1 in 10 patients):

• dizziness
• nausea

Common (may occur less frequently than 1 in 10 patients):

• anemia, thrombocytopenia (decreased platelet count, which increases the risk of bleeding and bruising)
• extrapyramidal disorders (e.g., dizziness, gait disturbances, muscle stiffness), stupor, drowsiness, seizures, memory disorders, headache, eye pain, dizziness
• hearing impairment
• vomiting, gastrointestinal disorders (mainly gastrointestinal hypertrophy), oral inflammation, stomach pain, diarrhea (frequent in some patients at the beginning of treatment) usually transient after a few days without the need to discontinue treatment
• hypersensitivity, transient and (or) dose-dependent hair loss, nail disorders, and nail bed disorders
• hyponatremia (decreased sodium concentration in the blood), weight gain, which should be observed, as it is associated with polycystic ovary syndrome
• bleeding
• liver damage
• irregular menstrual cycles
• confusion (disorientation), hallucinations, aggression, excitement, attention disorders
• urinary incontinence

Uncommon (may occur less frequently than 1 in 100 patients):

• leukopenia (significant decrease in white blood cell count), pancytopenia (significant decrease in blood cell count, which can cause weakness, easy bruising, or predispose to infections)
• sepsis, encephalopathy (brain damage), lethargy (state of lethargy and lack of reaction to stimuli), transient parkinsonian symptoms, coordination disorders, tingling and numbness, increased seizure activity
• pleural effusion
• pancreatitis, sometimes fatal
• vascular purpura, rash, hair disorders (such as abnormal hair structure, changes in hair color, abnormal hair growth)
• decreased bone mineral density, osteopenia, osteoporosis, and fractures in patients taking sodium valproate for a long time
• syndrome of inappropriate secretion of antidiuretic hormone (SIADH), hyperandrogenism (excessive male-type hair growth, virilism, hirsutism, male-type baldness, and (or) elevated androgen levels)
• vasculitis
• decreased body temperature, moderate peripheral edema
• amenorrhea
• renal failure

Rare (may occur less frequently than 1 in 1000 patients):

• bone marrow failure, including the formation of abnormal red blood cells, agranulocytosis (significant decrease in neutrophil count), macrocytic anemia (low red blood cell count), macrocytosis
• decreased activity of coagulation factors (at least one), abnormal coagulation test results (such as prolonged prothrombin time, prolonged activated partial thromboplastin time

after activation, prolonged thrombin time, prolonged INR), biotin deficiency / biotinidase deficiency

• involuntary urination, interstitial nephritis, transient renal function disorders
• toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, severe hypersensitivity syndrome including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS)
• systemic lupus erythematosus, rhabdomyolysis
• hypothyroidism
• hyperammonemia (elevated ammonia levels in the blood), obesity
• myelodysplastic syndrome
• male infertility, polycystic ovary syndrome
• abnormal behavior, psychomotor hyperactivity, learning disorders (observed in children and adolescents)
• transient dementia, associated with transient brain atrophy, cognitive disorders, double vision

Frequency not known (frequency cannot be estimated from available data):

• congenital disorders and hereditary and (or) genetic diseases
• darker areas of skin and mucous membranes (hyperpigmentation)

You should immediately contact your doctor in case of the occurrence of any of the following serious undesirable effects, as urgent medical attention may be necessary:

• changes in behavior related or unrelated to increased seizure frequency or severity, especially when taking phenobarbital or during sudden dose increase of Convival Chrono
• weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of skin and eye whites) or recurrence of seizures - these symptoms may indicate liver damage
• coagulation disorders, spontaneous bruising, and bleeding
• skin and mucous membrane changes - very rarely, severe skin reactions may occur: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
• breathing difficulties, chest pain or feeling of pressure (especially during inhalation), shortness of breath, and dry cough due to fluid accumulation around the lungs (pleural effusion)

Additional Undesirable Effects in Children

Some undesirable effects of valproate occur more frequently or have a more severe course in children than in adults. They include liver damage, pancreatitis, aggression, excitement, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

Reporting Undesirable Effects

If you experience any undesirable effects, including those not listed in the leaflet, you should inform your doctor or pharmacist or nurse. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Undesirable effects can also be reported to the marketing authorization holder. Reporting undesirable effects can help gather more information on the safety of the medicinal product.

5. How to Store Convival Chrono

No special precautions are required for the storage of the medicinal product in terms of temperature.
Store the container tightly closed.
Store in a place out of sight and reach of children.
Do not use Convival Chrono after the expiration date stated on the packaging: EXP.
The expiration date refers to the last day of the given month.
The batch number is stated on the packaging: Lot.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Convival Chrono Contains

The active substance of the medicinal product is sodium valproate (Natrii valproas).
Each prolonged-release tablet contains 300 mg of sodium valproate.
Excipients: citric acid monohydrate, ethylcellulose (100 cps), ammonio methacrylate copolymer (type B) (Eudragit RS30D) (contains sorbic acid), talc, colloidal silicon dioxide, magnesium stearate;
Coating: ammonio methacrylate copolymer (type A) (Eudragit RL30D) (contains sorbic acid), ammonio methacrylate copolymer (type B) (Eudragit RS30D) (contains sorbic acid), talc, sodium carmellose, titanium dioxide (E 171), triethyl citrate, vanillin.

What Convival Chrono Looks Like and Contents of the Package

White oval prolonged-release tablets with a dividing line and the inscription CC3 on one side. The tablet can be divided into two equal doses.
Package sizes:
50 tablets
100 tablets
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach,
Austria
To obtain more detailed information, please contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of Last Update of the Leaflet: